MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coil fibers detached in the sheath.The target lesion was located in the pulmonary artery fistula.A 3mm x 6cm pe f-idc interlock was selected for use.During the procedure, it was noted that this device was advanced and deployed prematurely in the microcatheter.Upon withdrawal of the coil some of the fibers had collected in the sheath.The procedure was completed with another of the same device.No complications reported and the patient is fine.
Event or Problem Description
It was reported that coil fibers detached in the sheath.The target lesion was located in the pulmonary artery fistula.A 3mm x 6cm pe f-idc interlock was selected for use.During the procedure, it was noted that this device was advanced and deployed prematurely in the microcatheter.Upon withdrawal of the coil some of the fibers had collected in the sheath.The procedure was completed with another of the same device.No complications reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: only the main coil was returned for product analysis, and it was found in good conditions.Since only the main coil was received the functional inspection could not be performed.Dimensional inspections revealed that the overall dimension of the coil arm, zap tip and primary coil were within the specification.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16109414
• Report Number: 2124215-2022-54928
• Device Sequence Number: 7524414
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029719918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male